MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; INSTRUMENT, STEREOTAXIC

Model Number UNK_NAV_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Edema (1820); Hematoma (1884); Hemorrhage/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Dysphasia (2195); Post Operative Wound Infection (2446); Confusion/ Disorientation (2553)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value is the mean age of the patients in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients in the article as specific patients could not be identified.Please note that this date is based off of the date the article was published online as the event dates were not provided in the published literature.Article citation is included.System product number and serial number not provided in journal article.Udi not available for this system.Other relevant device(s) are: product id: unk_nav_comp, serial/lot #: unknown, ubd: unknown, udi#: unknown.No 510k provided as system is unknown.No evaluation was performed as this event was reported in literature.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: yasunori nagahama, md, alan j.Schmitt, md, daichi nakagawa, md, adam s.Vesole, bs, janina kamm, psyd, christopher k.Kovach, phd, david hasan, md, mark granner, md, brian j.Dlouhy, md matthew a.Howard iii, md, and hiroto kawasaki, md, intracranial eeg for seizure focus localization: evolving techniques, outcomes, complications, an combining surface and depth electrodes, j neurosurg, volume 130, 2019, pages 1180¿1192, published online may 25, 2018; doi: 10.3171/2018.1.Jns171808.Abstract: objective intracranial electroencephalography (ieeg) provides valuable information that guides clinical decision- making in patients undergoing epilepsy surgery, but it carries technical challenges and risks.The technical approaches used and reported rates of complications vary across institutions and evolve over time with increasing experience.In this report, the authors describe the strategy at the university of iowa using both surface and depth electrodes and analyze outcomes and complications.Methods the authors performed a retrospective review and analysis of all patients who underwent craniotomy and electrode implantation from january 2006 through december 2015 at the university of iowa hospitals and clinics.The basic demographic and clinical information was collected, including electrode coverage, monitoring results, outcomes, and complications.The correlations between clinically significant complications with various clinical variables were analyzed using multivariate analysis.The fisher exact test was used to evaluate a change in the rate of complications over the study period.Results ninety-one patients (mean age 29 ± 14 years, range 3¿62 years), including 22 pediatric patients, underwent ieeg.Subdural surface (grid and/or strip) electrodes were utilized in all patients, and depth electrodes were also placed in 89 (97.8%) patients.The total number of electrode contacts placed per patient averaged 151 ±58.The duration of invasive monitoring averaged 12.0 ± 5.1 days.In 84 (92.3%) patients, a seizure focus was localized by ictal onset (82 cases) or inferred based on interictal discharges (2 patients).Localization was achieved based on data obtained from surface electrodes alone (29 patients), depth electrodes alone (13 patients), or a combination of both surface and depth electrodes (42 patients).Seventy-two (79.1%) patients ultimately underwent resective surgery.Forty-seven (65.3%) and 18 (25.0%) patients achieved modified engel class i and ii outcomes, respectively.The mean follow-up duration was 3.9 ± 2.9 (range 0.1¿10.5) years.Clinically significant complications occurred in 8 patients, including hematoma in 3 (3.3%) patients, infection/osteomyelitis in 3 (3.3%) patients, and edema/compression in 2 (2.2%) patients.One patient developed a permanent neurological deficit (1.1%), and there were no deaths.The hemorrhagic and edema/compression complications correlated significantly with the total number of electrode contacts (p = 0.01), but not with age, a history of prior cranial surgery, laterality, monitoring duration, and the number of each electrode type.The small number of infectious complications precluded multivariate analysis.The number of complications decreased from 5 of 36 cases (13.9%) to 3 of 55 cases (5.5%) during the first and last 5 years, respectively, but this change was not statistically significant (p = 0.26).Conclusions an ieeg implantation strategy that makes use of both surface and depth electrodes is safe and effective at identifying seizure foci in patients with medically refractory epilepsy.With experience and iterative refinement of technical surgical details, the risk of complications has decreased over time.Reported events: one patient developed a permanent neurological deficit related to a surgical complication.This patient developed a left frontal intraparenchymal hemorrhage associated with depth electrode placement and had moderate aphasia.Emergency removal of the electrodes and termination of the monitoring without seizure focus resection was required.One patient developed a large hematoma with significant neurological decline, right-sided epidural hematoma, requiring emergency removal of the electrodes and termination of the monitoring without seizure focus resection.One patient had a significant hemorrhagic complication that required emergency evacuation of an epidural hematoma during the monitoring period.The patient continued the monitoring and ultimately underwent anterior temporal lobectomy (atl).The patient achieved a modified engel class ib outcome at 5.7 years.Two patients had a surgical site infection, enterobacter aerogenes in one case and coagulase-negative staphylococcus in the other case, noted within a few weeks after electrode removal and seizure focus resection.Both required debridement and removal of a bone flap.One of the patients had underwent left atl resulting in an engel class iiia outcome at 7.6 years.The other patient underwent right atl and achieved engel class ia at 3.1 years.One patient had a delay surgical site infection that presented about 19 months after the patient underwent left atl and left frontal lesionectomy.Debridement and removal of the bone flap was required.Purulent fluid was noted intraoperatively, no organism grew on cultures.The patient was empirically treated with a 4-week course of intravenous cefepime.Seizure focus resection resulted in engel class ib at 1.9 years.One patient had clinically significant cerebral edema and brain compression that required surgical intervention.Significant aphasia and confusion developed and additional surgery was required during the monitoring for temporary removal of the bone flap.The patient ultimately underwent right arl and achieved engel class ia outcome at 1.9 years.One male patient had clinically significant cerebral edema and brain compression.The patient developed aphasia after electrode implantation which persisted throughout the monitoring period.The patient's seizure focus was localized to the left temporal lobe and the aphasia precluded functional mapping of the language area prior to tailored left atl.The patient underwent electrode removal without atl and recovered from aphasia soon after electrodes were removed.The patient underwent tailored left atl during an awake craniotomy and intraoperative language mapping several months later.The patient achieved engel class ia outcome at 3 years.One patient required an additional operation to reposition some of the electrodes and place additional electrodes because the original electrodes did not cover the seizure onset zone.The seizure focus was subsequently identified and the patient underwent resective surgery.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9087146
• MDR Text Key: 161195904
• Report Number: 1723170-2019-04936
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 29 YR